EUCTR2020-001419-25-PLActive, not recruitingPhase 1
Preoperative intraperitoneal chemotherapy in adjuvant hyperthermiaadjunctive therapy in advanced gastric cancer with high-risk of peritoneal recurrence - a multicentre randomized trial - GastricCHIMERAtrial
Jagiellonian University Medical College0 sites600 target enrollmentStarted: January 5, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- gastric cancer confirmed in histological examination of material taken during gastroscopy and biopsy of the tumour
- •- advanced gastric cancer (cT3/T4a, cN0-3b)
- •- no distant metastases on chest, abdominal and pelvic computed tomography (cM0)
- •- age 18-75
- •- signed written informed consent
- •-completion of at least 3 cycles of preoperative FLOT chemotherapy
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
Exclusion Criteria
- •- lack of confirmation of gastric cancer in histologic examination of biopsy material taken during gastroscopy
- •- age > 75
- •- Performance status 3 or higher in ECOG/WHO scale
- •- previous abdominal surgery other than appendectomy or laparoscopic cholecystectomy
- •- pregnancy or lactation
- •- lack of written informed consent
- •- other simultaneous neoplasm
- •- previous systemic treatment or radiotherapy for other neoplasm
- •- serious dysfagia requiring surgical treatment before previous chemotherapy
- •- lack of qualification to perioperative chemotherapy by multidisciplinary team (MDT)
Investigators
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